Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

NCT01479491 | Completed

• 1 other identifier: 116259
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged \<12 months after introduction of the Rotarix vaccination in Japan.

Conditions

Intussusception

Keywords

Japan; Retrospective; Observational; Epidemiological study; Children aged < 12 months; Intussusception

Outcome Measures

Primary Outcomes (2)

• Occurrence of IS in subjects aged < 12 months

  Between January 2005 and April 2011 (6 years)

• Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan

  Between January 2005 and April 2011 (6 years)

Secondary Outcomes (2)

• Number of IS cases hospitalized more than once among subjects aged < 12 months.

  Between January 2005 and April 2011 (6 years)

• Occurrence of IS cases by calendar months and year among subjects aged < 12 months

  Between January 2005 and April 2011 (6 years)

Study Arms (1)

Case Group

Children aged \< 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB).

Other: Data collection

Interventions

Data collection OTHER

Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.

Case Group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged \<12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.

You may qualify if:

• A male or female infant aged \< 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
• An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Intussusception

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 22, 2012

Record last verified: 2012-10